Label: URODEL- cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal serrulata, staphysagria, uva ursi tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated November 7, 2023

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  • Drug Facts

  • Active Ingredients & Purposes

    Active ingredients** (HPUS)

    (in each 300 mg tablet contains equal parts of:)

    Purposes*

    Cantharis vesicatoria 6X .....................

    Sharp burning pain during urination
    Clematis erecta 6X ...............................

    Burning sensation
    Cubeba officinalis 6X .............................

    Frequent urination, yellow discharge
    Echinacea angustifolia 6X .....................

    Bladder inflammation
    Ranunculus bulbosus 6X ......................Frequent urging to urinate
    Sabal serrulata 6X ........................................Painful urination
    Staphysagria 6X ..................................

    Pressure on the bladder
    Uva ursi 6X ............................................

    Constant urination and straining

    The letters HPUS indicate that this ingredient is officially included in the homeopathic Pharmacopeia of the United States.

  • Uses*

    Temporarily relieves symptoms associated with urinary tract infections

    • burning sensation when urinating
    • frequent urge to urinate
    • painful urination
    • bladder inflammation
  • Warnings

    Stop use and ask a doctor if

    • symptoms persist, worsen, reoccur or are severe
    • you experience fever, chills, back pain, or bloody urine
    • an allergic reaction occurs, seek medical help right away

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of the reach of children.

    In case of an overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older: take at least 15 minutes prior to eating food or drinking. Slightly chew one (1) tablet and allow it to dissolve in the mouth. Use 3 times a day or up to 6 times a day for intense symptoms. Reduce to one tablet daily for 7 days after symptoms improve.
    • children under 12 years of age: do not use
  • Other information

    • store between 59°-86°F (15°-30°C) and protect from light
    • do not use if seal over cap is torn, broken, or missing

  • Inactive ingredients

    croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose

  • Questions & comments?

    1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • PRINCIPAL DISPLAY PANEL

    PDP Urodel

  • INGREDIENTS AND APPEARANCE
    URODEL 
    cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal serrulata, staphysagria, uva ursi tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP6 [hp_X]
    PIPER CUBEBA FRUIT (UNII: Z99L7429MA) (PIPER CUBEBA FRUIT - UNII:Z99L7429MA) PIPER CUBEBA FRUIT6 [hp_X]
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_X]
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF6 [hp_X]
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS6 [hp_X]
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO6 [hp_X]
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED6 [hp_X]
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White Tablet) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-406-301 in 1 CARTON11/07/2023
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/07/2023
    Labeler - Pharmadel LLC (030129680)
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